The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans responded to the new issues faced by ethical review arising from the development of science and technology,society,and ethics,as well as the requirements of laws and regulations for ethical review.It adapted to the continuous increase of investment in scientific and technological innovation research and the development of biotechnology in China,and expanded the applicable institutions and research types of the ethical review system.Facing the ethical review of life sciences and medical research involving humans is one of the practical forms of responsible research and innovation.Therefore,it is necessary to establish and improve the ethical review system,implement the"subject responsibility"of life sciences and medical research involving humans,carry out classified and hierarchical bioethics education,and enhance the consciousness of researchers,research managers,and students in responsible research and innovation.

OBJECTIVE To evaluate the consistency between the quetiapine LC-MS/MS kit and the laboratory-built method(reference method) in the detection results of quetiapine therapeutic drug monitoring. METHODS A total of 120 remaining plasma samples were collected from patients receiving quetiapine therapeutic drug monitoring from March to October in 2021. The plasma concentration of quetiapine was detected by kit and reference method respectively. The analysis of correlations and consistency was performed by outlier analysis, linear regression and Bland-Altman method. RESULTS No outliers were detected. The linear regression equation was Y=1.018X+4.400(r=0.998), indicating a good correlation. The Bland-Altman plot analysis showed good agreement between the two measurements. CONCLUSION The detection results of quetiapine LC-MS/MS kit and reference method are in good agreement. The kit can be used for clinical quetiapine treatment drug monitoring.

Objective:To carry out cytogenetic and molecular genetic analysis for two infertile patients carrying rare small supernumerary marker chromosomes (sSMC).Methods:Two infertile patients who received reproductive and genetic counseling at CITIC Xiangya Reproductive and Genetic Hospital on October 31, 2018 and May 10, 2021, respectively were selected as the study subjects. The origin of sSMCs was determined by conventional G banding, fluorescence in situ hybridization (FISH) and copy number variation sequencing (CNV-seq). Microdissection combined with high-throughput whole genome sequencing (MicroSeq) was carried out to determine the fragment size and genomic information of their sSMCs. Results:For patient 1, G-banded karyotyping and FISH revealed that he has a karyotype of mos47, XY, del(16)(p10p12), + mar[65]/46, XY, del(16)(p10p12)[6]/48, XY, del(16)(p10p12), + 2mar[3].ish mar(Tel 16p-, Tel 16q-, CEP 16-, WCP 16+ ). CNV analysis has yielded a result of arr[GRCh37]16p12.1p11.2(24999364_33597595)×1[0.25]. MicroSeq revealed that his sSMC has contained the region of chromosome 16 between 24979733 and 34023115 (GRCh37). For patient 2, karyotyping and reverse FISH revealed that she has a karyotype of mos 47, XX, + mar[37]/46, XX[23].rev ish CEN5, and CNV analysis has yielded a result of seq[GRCh37]dup(5)(p12q11.2)chr5: g(45120001_56000000)dup[0.8]. MicroSeq results revealed that her sSMC has contained the region of chromosome 5 between 45132364 and 55967870(GRCh37). After genetic counseling, both couples had opted in vitro fertilization (IVF) treatment and preimplantation genetic testing (PGT). Conclusion:For individuals harboring sSMCs, it is vital to delineate the origin and structural characteristics of the sSMCs for their genetic counseling and reproductive guidance. Preimplantation genetic testing after microdissection combined with high-throughput whole genome sequencing (MicroSeq-PGT) can provide an alternative treatment for carrier couples with a high genetic risk.

Objective To analyze the stresses in implanted titanium solid and bone trabecular prosthesis hip replacements.Methods A femur model was built inversely based on Mimics software,and optimized using Geomagic software,and then materialized by SolidWorks software.The osteotomized femur was assembled with the metal femoral stem to form a model,and then the model was imported into ABAQUS for finite element calculation.The upper femur was divided into four regions in different states of integration:medial proximal point(small trochanter region),lateral proximal region(large trochanter region),proximal point of the femoral stem(region around the mid-portion of the styloid process)and distal region(around the end of the styloid process and distal portion).Calculations were carried out over the femoral stresses before and after implantation of titanium solid and trabecular prostheses under gait and stair-climbing loads and the interfacial stresses when the region was unintegrated.The type of deformation at the bone interface was analyzed by means of a stress ellipsoid.Results At the small trochanter region,the stress shielding rates of the trabecular prosthesis under gait and stair climbing loads were reduced by 20.5％and 14.7％compared to the titanium solid prosthesis,respectively.In case of different integration states of the titanium solid prosthesis,the interface tensile stresses under the gait and stair climbing loads were up to 10.842 MPa and 12.900 MPa,and the shear stresses reached 7.050 MPa and 6.805 MPa,respectively;in case of different integration states of the trabecular prosthesis,the interface tensile stresses under the gait and stair climbing loads were up to 3.858 MPa and 4.389 MPa,and the shear stresses reached 4.156 MPa and 3.854 MPa,respectively.Under the 2 different loads,the inboard shear stress ellipsoid of the interface opened toward the sides and the bone interface showed tensile deformation;the outboard shear stress ellipsoid of the interface opened up and down and had compressive deformation.Conclusion After total hip arthroplasty,the overall performance of the trabecular prosthesis is better than that of the titanium solid prosthesis.The unintegrated edges of the prosthesis-bone interface are susceptible to stress concentrations and distortion which may result in occurrence of failures.[Chinese Medical Equipment Journal,2024,45(3):29-35]

Objective: To explore the safety and efficacy of excimer laser coronary angioplasty (ELCA) for the treatment of degenerated great saphenous vein graft (SVG). Methods: This is a single-center, prospective, single-arm study. Patients, who were admitted to the Geriatric Cardiovascular Center of Beijing Anzhen Hospital from January 2022 to June 2022, were consecutively enrolled. Inclusion criteria were recurrent chest pain after coronary artery bypass surgery (CABG), and coronary angiography confirmed that the SVG stenosis was more than 70% but not completely occluded, and interventional treatment for SVG lesions was planned. Before balloon dilation and stent placement, ELCA was used to pretreat the lesions. Optical coherence tomography (OCT) examination was performed and postoperative index of microcirculation resistance (IMR) were assessed after stent implantation. The technique success rate and operation success rate were calculated. The technique success was defined as the successful passage of the ELCA system through the lesion. Operation success was defined as the successful placement of a stent at the lesion. The primary evaluation index of the study was IMR immediately after PCI. Secondary evaluation indexes included thrombolysis in myocardial infarction (TIMI) flow grade, corrected TIMI frame count (cTFC), minimal stent area and stent expansion measured by OCT after PCI, and procedural complications (Ⅳa myocardial infarction, no reflow, perforation). Results: A total of 19 patients aged (66.0±5.6) years were enrolled, including 18 males (94.7%). The age of SVG was 8 (6, 11) years. The length of the lesions was greater than 20 mm, and they were all SVG body lesions. The median stenosis degree was 95% (80%, 99%), and the length of the implanted stent was (41.7±16.3)mm. The operation time was 119 (101, 166) minutes, and the cumulative dose was 2 089 (1 378, 3 011)mGy. The diameter of the laser catheter was 1.4 mm, the maximum energy was 60 mJ, and the maximum frequency was 40 Hz. The technique success and the operation success rate were both 100% (19/19). The IMR after stent implantation was 29.22±5.95. The TIMI flow grade of patients after ELCA and stent implantation was significantly improved (all P>0.05), and the TIMI flow grade of all patients after stent implantation was Grade Ⅲ. The cTFC decreased significantly after ELCA (33.2±7.8) and after stent placement (22.8±7.1) than preoperative level (49.7±13.0) (both P<0.001). The minimum stent area was (5.53±1.36)mm², and the stent expansion rate was (90.0±4.3)%. Perforation, no reflow, type Ⅳa myocardial infarction and other complications were not observed. However, postoperative high-sensitivity troponin level was significantly increased ((67.937±33.839)ng/L vs. (5.316±3.105)ng/L, P<0.001). Conclusion: ELCA is safe and effective in the treatment of SVG lesions and could improve microcirculation and ensure full expansion of stent.
Male ; Humans ; Aged ; Prospective Studies ; Percutaneous Coronary Intervention ; Lasers, Excimer/therapeutic use* ; Saphenous Vein/transplantation* ; Constriction, Pathologic ; Atherectomy, Coronary/methods* ; Myocardial Infarction ; Coronary Angiography ; Stents ; Treatment Outcome

【Objective】 To validate the performance of a nucleic acid testing(NAT) system for blood screening in the high-altitude Nagqu region of Tibet, in order to assess the capability of NAT in high-altitude areas and further enhance blood safety. 【Methods】 Various methods were employed to evaluate the analytical sensitivity, reproducibility, ability to prevent cross-contamination, and comparison between different NAT systems. 【Results】 The NAT system in the Nagqu region of Tibet achieved a 100% detection rate for high-concentration HBV DNA and HIV-1 RNA samples, and over 90% for medium-concentration samples. PROBIT analysis revealed the lower limits of detection (LOD) for HBV DNA and HIV-1 RNA to be 8.29 IU/mL (95% CI, 5.88~20.55 IU/mL) and 40.52 IU/mL (95% CI, 30.26~85.92 IU/mL), respectively. For HCV RNA genotype 2a, the LOD was 97.14 IU/mL (95% CI, 71.00~182.67 IU/mL), all of which were lower than the declared minimum detectable concentrations in the instructions. Reproducibility analysis demonstrated a 100% level of consistency within the system. Cross-contamination performance verification showed a strong ability to resist cross-contamination. Comparative analysis of repeated testing of low-concentration HBV DNA samples and multi-system testing in plain areas revealed consistency rates of 77.78%(14/18) and 77.27%(17/22), respectively, indicating certain differences between the NAT system in Nagqu region and other systems. 【Conclusion】 The NAT system exhibited excellent performance in blood screening at high altitudes. The results of performance validation in high-altitude blood screening NAT systems were largely consistent with those in plain areas, providing a reliable basis for enhancing blood safety in high-altitude regions.

Objective:To investigate the safety and effectiveness of Solitaire FR with intracranial support catheter for mechanical thrombectomy (SWIM) in the treatment of cerebral venous sinus thrombosis (CVST).Methods:Patients with progressive CVST treated with SWIM technology in the Neurology Department, Zhongshan Hospital of Chinese Medicine Affiliated to Guangzhou University of Chinese Medicine from June 2019 to March 2022 (including 4 patients with intracranial hemorrhage) were retrospectively included. The venous sinus recanalization after procedure and during follow-up was observed. The modified Rankin Scale (mRS) was used to evaluate the outcome at 3 months after procedure.Results:A total of 9 patients with progressive CVST were treated with SWIM technology, including 6 males with a median age of 37.0 years (range, 15-78). Immediately post-procedural angiography showed complete recanalization of the venous sinuses in 6 cases and partial recanalization in 3 cases. At 3 months after procedure, the mRS score showed that 3 cases was 0, 3 cases was 1, 2 cases was 2, and 1 case was 4.Conclusion:SWIM technology may be a safe and effective method in the treatment of progressive CVST.

Objective:To investigate the risk factors for futile recanalization in patients with acute anterior circulation large vessel occlusion after endovascular mechanical thrombectomy (EMT), and establish a nomogram model predicting futile recanalization in these patients.Methods:One hundred and eighty-eight patients with acute anterior circulation large vessel occlusion after EMT were enrolled from Department of Neurology, Zhongshan Hospital of Chinese Medicine, Guangzhou University of Chinese Medicine from January 2018 to December 2021. Patients were divided into futile recanalization group and effective recanalization group according to whether futile recanalization occurred; futile recanalization was defined as successful recanalization showed by immediate postoperative DSA (modified thrombolysis in cerebral infarction [mTICI] ≥2b), but poor functional outcome (modified Rankin Scale [mRS] scores>2 90 d after surgery). The clinical data were compared between futile recanalization group and effective recanalization group. Multivariate Logistic regression analysis was used to screen the risk factors for futile recanalization. R software was used to establish a nomogram model for futile recanalization. C-index was used to evaluate the differentiation of the model, and correction curve was used to evaluate the accuracy of the line graph model prediction. Receiver operating characteristic (ROC) curve was used to evaluate the predictive efficiency of the nomogram model.Results:Ninety-two patients had futile recanalization. Compared with the effective recanalization group, futile recanalization group had significantly older age, significantly higher hemoglobin A1c on admission, significantly longer time from puncture to vascular recanalization, significantly higher proportions of patients with hypertension history and poor collateral circulation, and significantly different severities of stroke and white matter hyperintensities (WMHs) and distribution of occlusive sites ( P<0.05). Multivariate Logistic regression analysis showed that age, history of hypertension, time from puncture to vascular recanalization, poor collateral circulation, severe WMHs, and moderate-severe stroke were independent risk factors for futile recanalization after EMT in patients with acute anterior circulation large vessel occlusion ( P<0.05). A nomogram model of futile recanalization was established according to the above 6 factors, with C-index of 0.862 ( 95%CI: 0.809-0.914); the calibration curve of the model was highly coordinated to the ideal model curve; area under the ROC curve of futile recanalization was 0.862 ( 95%CI: 0.809-0.914, P<0.001). Conclusions:Acute anterior circulation large vessel occlusion patients with older age, history of hypertension, longer time from puncture to vascular recanalization, poor collateral circulation, severe WMHs, and moderate-severe stroke trend to have futile recanalization after EMT. This nomogram can predict futile recanalization after EMT.

Aim To explore the effect of Taohong Siwu Decoction on apoptosis and EMT of pulmonary fibrosis model rats by JAK2/STAT3 signaling pathway. Methods Forty SD rats were randomly divided into control group, model group, methylprednisolone group, Taohong Siwu Decoction low-concentration, high-concentration group respectively, with eight cases in each group. The intratracheal injection of bleomycin was applied to induce IPF rat models. HE and Masson staining were performed to observe the pathological changes of lung tissues in each group. ELISA was used to detect the contents of TNF-α, MMP-7 and TGFβ-l in serum of rats. Immunohistochemistry and Western blot were applied to detect the protein expression of JAK2, pJAK2, STAT3, p-STAT3, E-cadherin, α-SMA in lung tissues. RT-PCR was applied to detect the expression of JAK2, STAT3, Bcl2 and Bax genes in lung tissues. Results Compared with control group, the degree of alveolar inflammation and fibrosis degree, the contents of TNF-α, MMP-7 and TGFβ-1 in serum, the levels of JAK2, p-JAK2, STAT3, p-STAT3, α-SMA protein expression, JAK2, STAT3, Bax gene expression were up-regulated, and the levels of Bcl-2 gene and E-cadherin protein expression were down-regulated in lung tissues. Compared with model group, the degree of alveolar inflammation and fibrosis, the contents of TNF-α, MMP-7 and TGFβ-1 in serum, the levels of JAK2, p-JAK2, STAT3, p-STAT3, α-SMA protein expression, JAK2, STAT3 and Bax gene expression were reduced, while the levels of Bcl-2 gene and E-cadherin protein expression were elevated in Taohong Siwu Decoction high-concentration group. Conclusions Taohong Siwu Decoction may regulate JAK2/STAT3 signaling pathway, down-regulate Bax, α-SMA and up-regulate Bcl-2, E-cadherin expression to induce apoptosis and EMT in rat model of pulmonary fibrosis, thus playing an anti-pulmonary fibrosis role.

ObjectiveTo explore the therapeutic effect and possible mechanism of Banxia Xiexintang and its disassembled prescriptions in regulating the flora disorder induced by mixed antibiotics in young rats. MethodSeventy male BALB/C young rats were randomly assigned into 7 groups： blank group， model group， Bifidobacterium tetralogy viable tablets （0.68 g·kg^-1） group， Banxia Xiexintang （9.1 g·kg^-1） group， Xinkai （3.19 g·kg^-1） group， Kujiang （1.82 g·kg^-1） group， and Ganbu （4.1 g·kg^-1） group， with 10 rats in each group. Except the blank group， the other groups were given mixed antibiotics by gavage to induce intestinal flora disorder. After 14 days， the rats in different drug groups were administrated with corresponding drugs by gavage， and those in the blank group and model group with the same amount of normal saline once a day for 14 days. After that， fecal samples were collected aseptically for 16S rDNA sequencing of intestinal flora， and lipopolysaccharide （LPS， 10 mg·kg^-1） was injected intraperitoneally to induce inflammatory reaction. The tissue morphology of colonic mucosa was observed via hematoxylin-eosin （HE） staining， and the macrophage infiltration of colonic mucosa was observed via toluidine blue staining and immunohistochemistry. The expression of interleukin-1β （IL-1β）， interleukin-6 （IL-6）， interleukin-8 （IL-8）， tumor necrosis factor-α （TNF-α）， and interleukin-10 （IL-10） mRNA were determined by real-time fluorescence quantitative polymerase chain reaction （Real-time PCR）. ResultCompared with the blank group， the modeling changed the intestinal flora structure of the young rats （P<0.01）， damaged the colonic mucosa， reduced the macrophage infiltration， and down-regulated the mRNA levels of IL-1β， IL-6， IL-8， TNF-α， and IL-10 （P<0.01）. Compared with the model group， bifidobacterium quadruple viable tablets， Banxia Xiexintang and its disassembled prescriptions increased the diversity of intestinal flora and the relative abundance of beneficial bacteria such as Bacteroidetes and Firmicutes （P<0.01）. At the same time， they ameliorated colonic mucosal injury （P<0.05， P<0.01）， increased macrophage infiltration （P<0.05， P<0.01）， and up-regulated the mRNA levels of IL-6， IL-8， and TNF-α （P<0.01）. The mRNA level of IL-1β was up-regulated in Bifidobacterium tetralogy viable tablets， Banxia Xiexintang， Kujiang， and Ganbu groups （P<0.01）， and that of IL-10 was up-regulated in Bifidobacterium tetralogy viable tablets， Banxia Xiexintang， Xinkai， and Ganbu groups （P<0.01）. ConclusionBanxia Xiexintang and the disassembled prescriptions can adjust the intestinal flora of young rats exposed to antibiotics and protect the immune barrier of colonic mucosa after intestinal flora disorder. In particularly， the whole prescription of Banxia Xiexintang demonstrates the best performance.